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Initiative Irrigation and Drainage Treatment (IIDT) for Postoperative Care of High Complex Anal Fistulas:A Prospective, Multicentre and Randomized Controlled Study

Initiative Irrigation and Drainage Treatment (IIDT) for Postoperative Care of High Complex Anal Fistulas:A Prospective, Multicentre and Randomized Controlled Study complex anal fistula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112383
Enrollment
Unknown
Registered
2025-11-13
Start date
2021-05-19
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Interventions

Test Group:Initiative Irrigation and Drainage Treatment
Control Group:standard dressing change using sterile vaseline gauze

Sponsors

Nanjing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) According to the above diagnostic criteria, finger examination,three-dimensional intraluminal B-ultrasound or Pelvic MRI,patients with high complex anal fistula. (2) Patients who have no obvious abnormalities in routine examination, do not take anticoagulant drugs and can operate on schedule. The wound shall be open and the length of wound edge shall exceed 10cm. (3) The age is between 18 and 60.ALL gender. (4) Patients without serious diseases such as cardiovascular and blood system diseases. (5) Agree to use the negative pressure drainage sponge in this study,and sign the informed consent,andcooperate with the follow-up

Exclusion criteria

Exclusion criteria: (1) Trauma-induced anal fistula,tuberculosis, inflammatory bowel disease and other special types of anal fistula (2) Patients with metabolic system diseases that may affect wound healing, such as diabetes and severe malnutrition. (3) Female patients in pregnancy or lactation; Patients who has mental illness and does not have full capacity for civil conduct (4) Patients with serious systemic diseases, such as malignant tumors, serious insufficiency of heart, lung, liver and kidney function, blood system diseases, etc (5) Allergic to sponge, semipermeable membrane and other ingredients

Design outcomes

Primary

MeasureTime frame
pain;

Secondary

MeasureTime frame
Quality-of-life;healing time;fistula closure rate ;

Countries

China

Contacts

Public ContactZhang Yang

Nanjing Traditional Chinese Medicine Hospital

21670235@qq.com+86 131 8283 5012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026